Life Sciences IP Due Diligence: Implications of Recent Decisions, Legislation, PTO Guidance on Diligence Analysis

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Patent
- event Date
Tuesday, April 8, 2025
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide counsel for conducting intellectual property due diligence in life sciences deals. The panel will discuss recent court decisions relating to patent rights that impact life sciences analyses. The panel will offer steps companies and counsel should take to adapt the due diligence analysis.
Faculty

Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.

Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.
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Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.

Dr. Bellows focuses on pharmaceutical and biotechnology patent strategy, including domestic and international patent preparation and prosecution, portfolio creation and management, and due diligence.  As part of his practice, he is particularly attuned to the strategic positioning and strengthening of patent portfolios encompassing clinically valuable assets in light of potential competitor challenges. Dr. Bellows represents a diverse range of clients, from entry-level and emerging start-ups to global corporations.

Ms. Knowles provides global guidance on complex IP matters, patent litigation strategy and assistance, licensing, patent prosecution, opinions, obtaining and protecting the full value of innovation, investor support and monetization of assets. She is an intellectual property attorney with 30 years of experience in global corporate and private practice. She has acted as an expert witness on licensing matters in several disputes involving large pharmaceutical companies. From 2006-2010, she was the Senior Vice President and Chief Patent Counsel at GlaxoSmithKline, where she served as the worldwide head of patents for all litigation and transactional matters.
Description
The continued success of a life sciences company often relies on successful partnerships. Many collaborations and transactions involving life sciences IP call for due diligence to be conducted. Further, it would benefit life sciences companies to evaluate their IP and assess their IP strategy, including Orange Book listing strategy for small molecules, regularly. This will help the company identify and address potential issues and better prepare for potential partnerships or transactions.
Case law developments in written description law, obviousness and "blocking patents," obviousness-type double patenting and terminal disclaimers, AIA on-sale bar, the doctrine of equivalents, means-plus-function claims, and induced infringement for FDA-approved products are examples of changes that may impact a life science due diligence investigation.
Listen as our authoritative panel of patent attorneys provides insights into how recent court decisions relating to patent rights and due diligence will impact life sciences pipelines and reshape future business analyses. The panel will offer steps companies and counsel should take to adapt their due diligence analyses.
Outline
- Recent cases
- USPTO guidance
- Best practices for life sciences IP due diligence
Benefits
The panel will review these and other relevant issues:
- What are the best approaches for counsel to identify the IP assets to review during due diligence?
- What implications do recent court decisions have on the IP due diligence process in the life sciences?
- How should counsel address IP ownership and inventorship questions that arise during due diligence?
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